ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479— 510(k) K003259

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K003259 for ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479, Substantially Equivalent on 2001-06-13. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code LGD
Advisory panel: Microbiology
Date received: 2000-10-18
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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Adverse events under product code LGD

product code LGD

Malfunction: 502
Total: 502

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.